Unitary molded elastomer conduit for use with a medical infusion pump

ABSTRACT

A unitary molded elastomer conduit for use with a medical infusion pump. The molded conduit includes a plurality of elongated tubular sections defining a continuous lumen therethrough. A first interior surface of the molded conduit includes an interior region having surface characteristics for clamping off the lumen to stop the flow of fluid transport, or for clamping the lumen for use with the peristaltic mechanism of the medical infusion pump. Another interior surface is provided in the molded conduit which is associated with another of the plurality of elongated sections of the integral elastomer conduit. The second interior surface defines a second interior region having surface characteristics for coupling ultrasound across the conduit traversed to the lumen in order to detect gas entrainment and the like. The second interior region thus provides a textured surface relative to the first interior region to direct the signal energy from the signal coupled across the conduit traversed to the lumen. Additionally, external features may be provided for positioning the plurality of elongated tubular sections of the conduit relative to the peristaltic pumping mechanism of the medical infusion pump for fluid transport and characterization.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation-in-part of U.S. application Ser. No. 08/398,886,filed Mar. 6, 1995 now U.S. Pat. No. 5,904,668.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention is directed to a cassette for an infusion pumpwhich may be inserted into and removed from the pump. More particularly,the present invention relates to an infusion pump cassette having aunitary injection molded elastomer conduit for fluid transport with amedical infusion pump.

2. Background and Description of Related Art

An infusion pump is used to automatically administer liquid medicant toa patient. The liquid medicant is supplied from a source of medicant andpumped into the patient via a catheter or other injection device. Themanner in which the liquid is infused is controlled by the infusionpump, which may have various modes of infusion, such as a continuousmode in which the liquid medicant is continuously infused at a constantrate; or a ramp mode in which the rate of infusion gradually increases,then remains constant, and then gradually decreases. With the costsavings that may be attained today using home health care, smallportable medical infusion pumps have become common for use in hometreatment to provide for instance chemotherapy, pain management, and thelike. These treatments often require the controlled infusion regimensdiscussed herein.

Portable medical infusion pumps typically run open loop for displacing avolume of medicament fluids with the peristaltic pumping mechanism ofthe medical infusion pump. The pump chamber of the infusion pumpcassette displaces predetermined amounts of the medicament fluidsinfused with the stroke volume defined by the elongated tubular sectionsof the fluid transport swept through the conduit of the pump cassettewhich supports the elongated conduit. Thus, volumetric flow rate isdetermined in part by the controlled dimensional tolerances of theelongated tubular section inner diameter and length. A cassette utilizedby the infusion pump is typically disposable, and thus must bemanufactured in a cost effective manner, while requiring consistentcassette operation defined through the dimensional tolerances of thepump chamber provided by the cassette assembly.

Drugs being used with home therapy are increasingly becoming expensivefor such things as therapies that may be involved in treatment ofpulmonary hypertension, chemotherapy, and the like. Additionally, keepvein open (KVO) applications require replenishing of the liquidmedicament supply periodically by a nurse or other medical professionalwhich may from time to time visit the patient at home. It is important,therefore, to be able to know with a degree of certainty that themedicament is being delivered to the patient within a narrow therapeuticrange for effective treatment for patients on closely monitoredtreatments. Also, where the medications are costly, it would beadvantageous to be assured that the leftover drugs of the medicamentbags are minimal to avoid waste, since after they are used in treatment,these drugs must be discarded and cannot be recycled for later use.

Additionally, the medicament liquid should not become depleted prior tothe arrival of medical personnel for replacing the regimen. In the caseof a KVO application, premature termination of the application mayresult in clotted access devices which are blocked by blood clotsrequiring considerable additional effort by the medical personnelresponsible for the home therapy. Thus, it is important to maintaintight tolerances for and improve the accuracy of such portable medicalinfusion pump equipment.

One such cassette or module which may be inserted into and removed fromthe pump, is disclosed in U.S. Pat. No. 5,257,978 to Haber et al. Amodule disclosed by Haber et al. receives a length of an intravenousline in its interior, and a length of silicone tubing is connected tothe intravenous line to form a single continuous conduit. The module isinsertable into an infusion pump, in the form of a peristaltic pump, viaa door which may be opened and closed. The Haber et al. pump isconstructed so that it will operate only when the door is completelyclosed.

Additionally, U.S. Pat. No. 5,551,850 to Williamson et al. discloses theuse of an elastomeric conduit used in the pump chamber, which isintended to result in a uniform pump chamber discharge volume by usingmaterials of a relating constant storage modulus or stiffness. TheWilliamson et al. pump chamber assembly includes a pump chamber made ofpolyurethane tubing which was selected for the pump chamber because ofits ability to rebound and its stiffness creating a hydraulically rigidsection that resists volume changes due to system pressure variances.

The pump chamber assembly also includes inlet and outlet valve tubescoupled to the pump chamber, and inlet and outlet clips separate fromthe pump chamber and valve tube for securing the pump chamber to thecassette module of the infusion pump. Williamson et al. teach the use ofparticular materials not only for their mechanical properties, but alsofor the ability to solvent bond the component materials to othercomponent materials of the assembly. Although Williamson et al.acknowledge that silicone has desirable features, including a relativelyconstant storage modulus or stiffness and a relatively low dynamicmechanical analysis tangent versus temperature over a range of operatingtemperatures, however, the silicone is considered to be difficult tosolvent bond to other materials and therefore not suitable in amulticomponent solution. The use of solvent bonded materials in the pumpchamber however adds cost to the manufacture and increases thedifficulty of assembly of the pump chamber for use in the medicalinfusion pump cassette module, as well as, creating the possibility formalfunction due to failure of the solvent bond between materials.Therefore, it would be desirable to provide a unitary molded elastomerconduit for use with the pump chamber of the infusion pump cassettemodule, which improves the manufacturability and reliability, as well asthe cost of the overall medical infusion pump system.

SUMMARY OF THE INVENTION

A cassette adapted to be insertable into and removable from an infusionpump has a housing carrying a flexible tubing. The flexible tubingincludes a unitary elastomer conduit such as a pyrogen free silicone.The flexible tubing is provided as a molded elastomer conduit havingintegral elongated tubular sections. The molded elastomer conduit isreceived by the cassette assembly for use with the medical infusionpump. The unitary molded elastomer provides for a single pump chambercomponent which simplifies the manufacture of the cassette module, whileat the same time tight dimensional tolerances can be maintained throughthe molding process. To this end, the molding of the elastomer conduitprovides more consistent manufacture and tighter tolerances than may beachieved through the extrusion of elastomer tubing for use as acomponent part of the pump chamber of the medical infusion pump. Themolding process also facilitates the use of one or more externalfeatures such as alignment tabs on the outside of the conduit forpositioning of the conduit in the cassette. In the describedembodiments, the mold also provides for predetermined surfacecharacteristics which enhance the overall medical pump operation bysmoothing or narrowing of interior and exterior surfaces and definedsurface features of the elastomer conduit to facilitate alignment of thetube in the cassette, clamping off of the lumen defined by the conduit,for coupling ultrasonic energy across the conduit such as ultrasonicwaves used for characterization of the fluid transport such asair-in-line detection and the like.

Briefly summarized, the present invention relates to a unitary moldedelastomer conduit for use with a medical infusion pump. The moldedconduit includes a plurality of elongated tubular sections defining acontinuous lumen therethrough. A first interior surface of the moldedconduit is associated with one of the plurality of elongated tubularsections, and includes a first interior region having surfacecharacteristics for clamping off the lumen to stop the flow of fluidtransport, or for clamping the lumen for use with the peristalticmechanism of the medical infusion pump. A second interior surface isprovided in the molded conduit which is associated with another of theplurality of elongated sections of the integral elastomer conduit. Thesecond interior surface provides a second interior region having surfacecharacteristics for effectively coupling a signal such as an ultrasonicenergy across the conduit traversed to the lumen in such a manner thatthe discrimination of air entrainment in the conduit and medicament isenhanced. The second interior region thus provides a textured surfacerelative to the first interior region to couple the signal energy acrossthe conduit traversed to the lumen. Additionally, external features maybe provided for positioning the plurality of elongated tubular sectionsof the conduit relative to the peristaltic pumping mechanism of themedical infusion pump for fluid transport and characterization.

These and other features and advantages of the present invention will beapparent to those of ordinary skill in the art in view of the detaileddescription of the preferred embodiment, which is made with reference tothe drawings, a brief description of which is provided below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an ambulatory infusion pump and a firsttype of cassette which is insertable into the pump;

FIG. 2A is a cross-sectional front view of a portion of the infusionpump of FIG. 1 with the cassette disposed therein;

FIG. 2B is a cross-sectional side view of a portion of the infusion pumpof FIG. 1 with the cassette disposed therein;

FIG. 3A is a cross-sectional front view of a portion of the infusionpump of FIG. 1 with a second type of cassette disposed therein;

FIG. 3B is a cross-sectional side view of a portion of the infusion pumpof FIG. 1 with the second type of cassette disposed therein;

FIG. 4A is a cross-sectional side view of the first type of cassette inwhich a flexible tube is clamped;

FIG. 4B is a top view of the cassette of FIG. 4A;

FIG. 5A is a front elevational view of a platen which forms part of thecassette of FIG. 4A;

FIG. 5B is a side elevational view of the platen of FIG. 5A;

FIG. 6 is a cross-sectional side view of a portion of the infusion pump;

FIG. 7 is a block diagram of the electronic components of the infusionpump of FIG. 1;

FIGS. 8A-8C illustrate various embodiments of the cassette sensor shownschematically in FIG. 7;

FIG. 9 is a flowchart of the overall operation of the infusion pump;

FIG. 10 is a flowchart of the ready-to-run step shown schematically inFIG. 9;

FIG. 11 is a flowchart of the operating system utilized by the infusionpump;

FIG. 12 is a flowchart of a turn-off routine performed during theoperation of the infusion pump;

FIGS. 13A-13C are flowcharts of three sensor routines performed duringthe operation of the infusion pump;

FIG. 14 is a flowchart of a backlight routine performed during theoperation of the infusion pump;

FIG. 15 illustrates a number of data-recording steps performed duringthe operation of the infusion pump;

FIG. 16 is a perspective view of the unitary molded elastomer conduitfor use with the medical infusion pump in accordance with the presentinvention;

FIG. 17 illustrates the elastomer conduit of FIG. 16 positioned within amedical infusion pump cassette module;

FIGS. 18 and 19 illustrate the plurality of elongated tubular sectionsdefining a continuous lumen to the unitary molded elastomer conduitshowing the various regions of the conduit for use with the medicalinfusion pump; and

FIGS. 20, 21, and 22 are cross-sectional views of the elastomer conduitof FIG. 19 illustrating the interior surfaces of the conduit associatedwith a plurality of the elongated tubular sections of the conduit.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A preferred embodiment of a battery-powered, ambulatory infusion pump 10in accordance with the invention is illustrated in FIG. 1 along with afirst type of cassette 12 which is insertable into the pump 10. Theportable pump 10 may be carried in a pouch or other device (not shown)attached to a patient so that the pump 10 may be carried wherever thepatient goes.

The infusion pump 10 has a keypad 14 via which a user may input data andcommands, a selectively back-lighted, dot matrix display 16 fordisplaying textual messages to the user, a light sensor 18 for detectingthe level of ambient light, and a pair of light-emitting diodes (LED)20, a green LED for indicating the normal operation of the pump 10 and ared LED for indicating an alarm or abnormal operating condition of thepump 10. As described below, the level of the light sensed by theambient light sensor 18 is used to control when the display 16 isbacklighted.

A door 30 is pivotally attached to the upper portion of the infusionpump 10 via a number of hinges 32. The underside of the door 30, whichis shown in FIG. 1, has a pair of slots formed therein in which a pairof metal rods 35 are fixed. As described below, each of the metal rods35 selectively engages a pair of slidable latching members to retain thedoor 30 in the closed position during operation of the pump 10.

An arcuate metal leaf spring 36 is disposed on the underside of the door30. The two ends of the leaf spring 36 are anchored by a pair ofretaining elements 38 fixed to the door 30. When the cassette 12, inwhich a flexible silicone tube 40 is disposed, is inserted into the pump10 and the door 30 is closed, the leaf spring 36 makes contact with andapplies a downward force on the upper surface 42 of a vertically movableplaten 44. As shown in FIGS. 1 and 4B, the upper surface 42 of theplaten 44 is disposed within an elongated slot or aperture 43 disposedin the upper surface of the cassette housing 12. The platen 44 has alower curved surface 46 against which the flexible tube 40 is pressed bya number of rollers 48 disposed on a conventional rotary pump wheel 49(see FIG. 2A) to facilitate pumping of liquid through the tube 40. Therotary pump wheel 49 is fixed to a gear 50 (FIG. 2B) which is driven bya drive belt (not shown) connected to a DC motor 51 (FIG. 7) via a geardrive assembly (not shown).

Liquid is supplied to the tube 40 via a supply tube 52 connected to asource of liquid, which may be a liquid supply container or bag (notshown) fixed to the housing of the pump 10. The liquid is infused intothe patient via a catheter or other injection device (not shown) fluidlyconnected to a length of tubing 54 fluidly connected to the tube 40. Thetubing 52, 54 may comprise conventional polyvinylchloride (PVC) tubinghaving an outside diameter slightly larger than the inside diameter ofthe flexible tube 40 so that the tubing 52, 54 may be inserted into theflexible tube 40 to effect a liquid-tight seal.

The tubing 52, 54 may be solvent-bonded to the cassette housing 12,which is plastic, to prevent the tubing 52, 54 from being inadvertentlypulled from the tube 40. As shown in FIG. 4A, the bottom portion of thecassette 12 has two semi-circular retaining members 56 integrally formedtherewith, each of which abuts a portion of the flexible tube 40 whereit overlaps the tubing 52, 54 to further prevent the tubing 52, 54 frombeing inadvertently pulled from the tube 40. A second pair of similarsemi-circular retaining members are integrally formed with the pumphousing at a point directly below the retaining members 56, as shown inFIGS. 2A and 3A, for the same purpose.

The cassette 12 has a flow-stop mechanism 60 that automatically clampsthe flexible tube 40 shut when the cassette 12 is not disposed in thepump 10 or when the pump door 30 is open. The flow-stop mechanism 60,which is shown in detail in FIGS. 2A and 2B, has a housing 62 in which avertically displaceable flow-stop member 64 and a spring 66 aredisposed. As shown in FIG. 2B, the flexible tube 40 passes through aslot 68 formed in the flow-stop member 64, and the spring 66 biases theflow-stop member 64 upwardly.

While the cassette 12 is disposed in the pump 10 with the door 30closed, one of the spring retaining members 38 makes contact with anupper surface 70 of the flow-stop member 64, thus preventing the spring66 from forcing the flow-stop member 64 upwards enough to cause theflexible tube 40 to be flattened by the bottom surface of the slot 68.When the door 30 is opened, or when the cassette 12 is not disposedwithin the pump 10, the spring 66 forces the flow-stop member 64 upwardsa distance sufficient to flatten the flexible tube 40, as shown in FIG.4A, so as to prevent any liquid flow therethrough.

When the cassette 12 is in the pump 10, as the pump door 30 is closed,one of the rollers 48 of the rotary pump wheel 49 will make contact withthe flexible tube 40, causing it to be clamped shut, as shown in FIGS.2A and 3A, and then subsequently, as the door 30 closes further, theflow stop member 64 will be forced downwards, unclamping the flexibletube 40. Thus, the tube 40 will be clamped at all times, either by oneof the rollers 48 or by the flow stop member 64. Similarly, as the door30 is opened, the flow stop member 64 will clamp the flexible tube 40before the roller(s) 48 of the rotary pump wheel 49 unclamp the tube 40,thus preventing any liquid free-flow through the tube 40.

When the cassette 12 is not inserted into the pump 10, the flow-stopmechanism 60 may be disabled by manually aligning a bore 74 (FIG. 2B) inthe flow-stop housing 62 with a bore 76 in the flow-stop member 64 andinserting a pin 78 (see FIG. 1) into the aligned bores 74, 76. Whenplaced in the bores 74, 76, the pin 78 will prevent the flow-stop member64 from being displaced upwardly by the spring 66, and thus prevent theflexible tube 44 from being flattened and the liquid flow from being cutoff.

FIGS. 3A and 3B illustrate a second type of cassette, which is showndisposed within the infusion pump 10. The only difference between thetwo types of cassettes 12 is the size and shape of the bottom portion ofthe flow-stop member 64. The bottom portion of the flow-stop member 64of the first type of cassette 12, shown in FIGS. 2A and 2B, is generallyspherical and does not extend outside of the flow-stop housing 62. Thebottom portion of the flow-stop member 64 of the second type of cassette12, shown in FIGS. 3A and 3B, has a downwardly angled finger 82 thatextends through a circular bore 84 disposed in the bottom of theflow-stop housing 62.

Referring to FIGS. 4A and 4B, the cassette 12 has a length L ofapproximately 9.7 centimeters (cm), a height H of approximately 1.5 cm,and a width W of approximately 0.8 cm. The outer diameter of theflexible tube 40 (when undistorted) is approximately 0.4 cm.

The upper surface 42 of the platen 44, which is shown in FIGS. 4A and4B, has an elongated central aperture 86 formed therein and is slightlycurved to generally conform to the arcuate shape of the leaf spring 36.As shown in FIGS. 5A and 5B, the platen 44 has a bottom portion 90 and atop portion 92, the bottom portion 90 being wider than the top portion92. The top portion 92 of the platen 44 is loosely disposed within theslot 43 (FIG. 4B) formed in the cassette 12 and is retained in the slot43 only by the presence of the flexible tube 40 beneath the bottom ofthe platen 44, as shown in FIG. 4A.

The infusion pump 10 has a latching mechanism 100, illustrated in FIG.6, for retaining the door 30 in its closed position. Referring to FIG.6, the latching mechanism 100 includes a pair of horizontally slidablemetal plates 102 a, 102 b which are supported by a flat portion of arotary pump wheel housing 104 and a pair of support beams 106. Each ofthe metal plates 102 a, 102 b has a respective pair of curved latchmembers 108 a, 108 b integrally formed therewith. A pair ofindependently operable door-release buttons 110 a, 110 b are disposed oneither side of the infusion pump 10. Each door-release button 110 a, 110b has a hollow cylindrical body portion 112 a, 112 b and a centralmember 114 a, 114 b disposed within the hollow body portion 112 a, 112b. Each of the central members 114 a, 114 b engages a respective end ofone of the slidable plates 102 a, 102 b. A pair of annular slots 116 a,116 b are formed in the body portions 112 a, 112 b, and a pair of ridges118 a, 118 b integrally formed with the pump housing are disposed withinthe slots 116 a, 116 b to limit the horizontal displacement of thedoor-release buttons 110 a, 110 b.

Each of the slidable plates 102 a, 102 b has a respective centralaperture 120 a, 120 b disposed therein, and a spring 122 is disposedwithin both of the central apertures 120 a, 120 b so as to spring-biasor force each of the slidable plates 102 a, 102 b against the centralmember 114 a, 114 b of the door-release button 100 a, 110 b with whichthe end of the slidable plate 102 a, 102 b makes contact. The spring 122may be retained within the apertures 120 a, 120 b by an L-shapedretaining member (not shown).

As shown in FIG. 6, the two curved latches 108 a, 108 b of each of theplates 102 a, 102 b engage both of the rods 35 fixed to the underside ofthe pump door 30, due to the force of the spring 122, thus preventingthe door 30 from being opened. Each plate 102 a, 102 b alone issufficient to keep the door 30 closed. To open the door 30, both of thedoor-release buttons 110 a, 110 b must be simultaneously depressed, inwhich case the slidable plates 102 a, 102 b are moved, against the forceof the spring 122, to cause the curved latches 108 a, 108 b to disengagethe metal rods 35, thus allowing the door 30 to be opened. The door 30may be provided with a spring or other means (not shown) to cause thedoor 30 to open automatically when both of the door-release buttons 110a, 110 b are pressed. Since both of the door-release buttons 110 a, 110b must be actuated to open the door 30, any inadvertent opening of thedoor 30 due to the infusion pump 10 being dropped or jarred is reducedor eliminated.

A block diagram of the electronics of the infusion pump 10 is shown inFIG. 7. Referring to FIG. 7, the infusion pump 10 includes a controller200 with a built-in analog-to-digital (A/D) converter 200 a, anelectrically programmable read-only memory (EPROM) 204 having a built-ininput/output (I/O) interface 204 a, a random-access memory (RAM) 208, areal-time clock 210 and the display 16, all of which are interconnectedby a communications bus 212. The display 16 has a backlight 220 which isselectively activated by an enable signal generated on a line 222interconnecting the controller 200 and the backlight 220. Both the RAM208 and the real-time clock 210 are connected to a battery 214 whichsupplies power to them only in the absence of system power (generated bya second battery 282). Since it is always powered, the RAM 208 is anon-volatile memory.

The controller 200, which may be a conventional microcontroller such asan 80C196KB commercially available from Intel Corporation, controls anaudible alarm generator 230 via a line 232, the LEDs 20 via a line 234,and an amplifier circuit 236 via a line 238. The amplifier circuit 236is connected to drive the pump motor 51 which drives the rotary pumpwheel 49. During normal operation, the controller 200 also sends aperiodic signal to a conventional watchdog timer 250 via a line 252. Ifthe controller 200 should fail to transmit the periodic signal to thewatchdog timer 250, which would indicate failure or malfunction of thecontroller 200, the watchdog timer 250 transmits a signal via a line 260to cause the alarm 230 to sound, transmits a signal via a line 262 tocause the red LED to be illuminated, and transmits a signal via a line264 to the amplifier circuit 236 to cause the pump motor 51 to stop.

The pump 10 has a number of sensors which sense various conditionsrelating to the operation of the pump. These sensors include an inputpressure sensor 270 for detecting the liquid pressure within theflexible tube 40 at a point upstream of the rotary pump wheel 49 and anoutput pressure sensor 272 for detecting the liquid pressure within theflexible tube 40 at a point downstream of the rotary pump wheel 49. Theinput pressure sensor 270 generates an analog signal, indicative of theinput pressure, which is transmitted to the A/D converter 200 a via aline 274, and the output pressure sensor 272 generates an analog signal,indicative of the output pressure, which is transmitted to the A/Dconverter 200 a via a line 276. Each of the pressure sensors 270, 272,which detect occlusions with the flexible tube 40 or the tubing 52, 54connected thereto, may be provided in the form of a strain gauge or beam(not show) which is in contact with the exterior of the flexible tube 40and a high-gain amplifier (not shown) connected to the strain beam.

The pressure sensors 270, 272 are connected to and receive power from apower switch 280 which is connected to a battery 282 through a systempower switch 284, a voltage regulator 286, and a system power line 287.The system power switch 284 selectively supplies power from the battery282 to the voltage regulator 286 based on the state of a pump on/offswitch 288 connected to the system power switch 284. The power switch280 is controlled by the controller 200 via the bus 212, the I/Ointerface 204 a, and a line 294 which interconnects the I/O interface204 a and the power switch 280.

The pump 10 has an air-in-line sensor 300, which may be provided in theform of a conventional piezoelectric transmitter and receiver (notshown) coupled to a sensing circuit (not shown), to detect the presenceof any significant air bubbles within the flexible tube 40. Theair-in-line sensor 300 receives power from a power switch 302 which isconnected to the system power line 287 and controlled by the controller200 via a line 304 connected to the I/O interface 204 a.

The pump 10 has a shaft encoder sensor 308 and a Hall-effect sensor 310which receive power from a power switch 312 coupled to the system powerline 287 and controlled by the controller 200 via a line 314. The shaftencoder sensor 308, which is disposed on the shaft of the motor 51, maybe a two-phase motion sensing encoder which provides two signal outputsto the controller 200. The rotational speed of the motor 51 and itsdirection of rotation are determined by the controller 200 based uponthe rate and phase relationship between the two signal outputs. TheHall-effect sensor 310 is disposed adjacent the rotary pump wheel 49 anddetects magnetic encoding on the pump wheel 49 for detecting rotation ofthe wheel 49.

A cassette sensor 320, which is also connected to the power switch 312,detects the type of cassette which is inserted into the pump 10. Asdescribed below, the pump 10 may accept different types of cassettes andtake different operating actions based upon the type of cassette whichis inserted. Various possible embodiments of the cassette sensor 320 areshown in FIGS. 8A-8C. Each embodiment includes a force-sensitiveresistive element 322 disposed in a sensing circuit. The circuits ofFIGS. 8A and 8B act as force-to-voltage converters (the amplifier 323 inFIG. 8B is an operational amplifier), and the circuit of FIG. 8C (whichincludes a Schmidtt trigger 324) acts as a force-to-frequency converter.

The force is generated by the physical contact between the downwardlyangled finger 82 of the second type of cassette 12 shown in FIGS. 3A and3B and the force-sensitive resistive element 322 when the cassette 12 isinserted into the pump 12 and the door 30 is closed. Since the firsttype of cassette 12 shown in FIGS. 2A and 2B has no downwardly extendingfinger, the insertion of that type of cassette does not result in anyphysical contact with the force-sensitive resistive element 322. Thus,the resistance of the resistive element 322 changes only when the secondtype of cassette 12 is inserted, thus causing the cassette sensor 320 togenerate an electrical signal (a voltage signal) in the cases of FIGS.8A and 8B and a frequency signal in the case of FIG. 8C) indicative ofthe type of cassette inserted on a line 325 connected to the I/Ointerface 204 a. The force-sensitive resistive element 322 is aconventional component which is commercially available from InterlinkElectronics of Carpinteria, Calif. As described below, other types ofsensors may be utilized.

Referring to FIG. 7, the ambient light sensor 18 is connected to a powerswitch 326 which is controlled by the controller 200 via a line 328 fromthe I/O interface 204 a. Signals generated by a door-open sensor 330, abolus infusion request switch 332, and the keypad 14 are transmitted tothe controller 200 via the I/O interface 204 a. Although not shown inFIG. 7 for purposes of simplicity, the controller 200, the EPROM 204,the RAM 208, and the display 16 are also connected to and receive powerfrom the system power line 287.

The operation of the infusion pump 10 is controlled by a computerprogram stored in the EPROM 204 and executed by the controller 200. Aflowchart of the overall operation is illustrated in FIG. 9. Referringto FIG. 9, when the pump 10 is turned on via the on/off switch 288, atstep 402 the pump is initialized and a test of the pump operation isperformed The pump 10 may be turned off temporarily during an infusion,in which case the pump 10 may continue the infusion when it is turnedback on, as described below. At step 404, if there is any remainingvolume of liquid to be infused by the pump or any additional timeremaining for an infusion, which would be the case where the pump wastemporarily turned off during an infusion, the program branches to step406, where the user is asked, via a message displayed on the display 16,whether the previous infusion should be resumed. If the user answers yes(via the keyboard 14), the program branches to a ready-to-run step 410.If the previous infusion is not to be resumed, the program branches tostep 412.

The infusion pump 10 has a lockout mode in which the user may beprevented from programming the infusion parameters, such as the volumeto be infused or the rate of infusion. For example, the pump 10 could beprogrammed by a medical assistant to deliver a particular infusionhaving a particular flow profile, flow rate, and volume to be infused.After programming that infusion, the medical assistant could place thepump in lockout mode, which would prevent the patient from changing anyof the infusion parameters. At step 412, if the pump 10 has beenpreviously placed in lockout mode, the program branches directly to theready-to-run step 410, bypassing all programming steps.

At step 412, if the pump is not in lockout mode, the program branches tostep 414, at which point the program prompts the user, via the display16, to input whether the patient should be allowed to program the pumpduring the subsequent infusion. If the pump is not to be programmable,the program branches to step 416 where a lockout sequence is performedby requesting the user to input which infusion modes should be lockedout. If the pump is to be programmable by the patient, the programbypasses step 416.

The infusion pump 10 has five basic modes of infusion: 1) a continuousmode in which the pump delivers a single volume at a single rate; 2) anauto-ramp mode in which the pump delivers liquid at a rate thatgradually increases to a threshold rate, stays constant at the thresholdrate, and then gradually decreases; 3) an intermittent mode in which thepump delivers discrete liquid volumes spaced over relatively longperiods of time, such as a liquid volume every three hours; 4) a custommode in which the pump can be programmed to deliver a unique infusionrate during each of 25 different time periods; and 5) a pain-controlledanalgesic (PCA) mode during which the pump will periodically infuseboluses of analgesic in response to periodic requests by the patient,which requests are made via the bolus-request key 332.

At step 418, the pump 10 generates on the display 16 the prompt“Continuous?” to the user. If the user desires to use the pump in itscontinuous mode, the user answers “yes” via the keypad 14, and theprogram branches to step 420 at which the continuous mode is programmedby the user by entering a number of infusion parameters, such as thedesired infusion rate, the volume to be infused, etc. At step 418, ifthe user does not want to use the continuous mode, the user answers“No”, and the program branches to step 422. Steps 422-436 are generallythe same as steps 418 and 420, except that the user may be prompted fordifferent infusion parameters, depending on which of the five possibleinfusion modes is selected.

After the completion of one of the steps 420, 424, 428, 432, or 436, theprogram branches to the ready-to-run step 410, a flowchart of which isshown in FIG. 10. Referring to FIG. 10, the ready-to-run step 410includes a step 440 at which the infusion rate and the volume to beinfused which were entered during one of the programming steps 420, 424,428, 432, 436, are shown on the display 16. Then the program waits atstep 442 until the “Run” key of the keypad 14 is pressed, at which pointthe program branches to step 444 where the cassette sensor 320 ischecked to determine which type of cassette has been inserted into theinfusion pump 10.

The infusion pump 10 has the capability to alter its operation basedupon the type of cassette 12 which is inserted into the pump 10, asdetermined by the cassette sensor 320. In one embodiment, the insertionof the cassette 12 shown in FIGS. 3A-3B, which is referred to herein asa “micro-set”, prevents the infusion pump 10 from performing an infusionif the programmed infusion rate exceeds a predetermined limit. In thisembodiment, at step 446, if a micro-set has been installed, the programbranches to step 448 where the infusion rate parameters entered duringone of the programming steps 420-436 are checked. At step 450, if theprogrammed infusion rate exceeds the predetermined limit, which may be99.9 milliliters/hour, the program branches to step 452 where the pumpgenerates a message on the display 16 to that effect and branches backto step 440 upon any key being pressed at step 454. If a micro-set wasnot installed as determined at step 446, the program skips steps 448-454and branches directly to the run mode 460 shown in FIG. 9.

Referring back to FIG. 9, during the run mode 460, the pump 10 infusesthe patient with a liquid medicant in accordance with the infusion modeselected at one of steps 418, 422, 426, 430, 434 and the infusionparameters entered at one of steps 420, 424, 428, 432, 436. The pump 10remains in the run mode 460 until the hold key is pressed, as determinedat step 462. Upon the occurrence of an alarm condition, an alarm isreported at step 464.

At step 462, if the hold key is pressed, the infusion is stopped at step466, and the pump 10 waits for the run key to be pressed at step 468 orthe on/off switch to be turned off at step 470.

Summarizing the operation described above, if the pump is to be utilizedin lockout mode, a medical assistant turns the pump on, programs thedesired infusion mode at one of steps 420, 424, 428, 432, 436, and thenturns the pump off. The programmed infusion parameters will be retainedin the nonvolatile memory 208. The medical assistant would then turn thepump back on, press the “No” key in response to the “Programmable?”prompt at step 414, enter the lockout information at step 416, and thenturn the pump off again. When the patient subsequently turned on thepump to perform the infusion (after a cassette 12 is primed with theliquid to be infused and inserted into the pump), the program wouldproceed from step 412 directly to the ready-to-run step 410, which wouldprevent the patient from altering the infusion parameters.

If the lockout mode was not utilized, the medical assistant or thepatient could turn the pump on, program the desired infusion mode, andthen press the “Run” key to start the infusion without every turning thepump off.

The ability of the pump to take different actions based upon the type ofcassette inserted into the pump could be utilized in many ways. Forexample, the pump could be utilized with any of four different types ofcassettes, and the pump could be preprogrammed with a unique infusionmode and/or a unique set of infusion parameters for each type ofcassette.

The different infusion modes could be based on the liquid medicant to beinfused. For some liquid medicaments, it may be desirable to utilize theauto-ramp mode of infusion so as not to “shock” the patient by startingthe infusion at a relatively large flow rate. These liquid medicamentswould be used with a type of cassette that, when inserted into the pump,would cause the pump to automatically set the infusion mode to theauto-ramp mode. Thus, in this example, the program illustrated in FIG. 9would branch from step 414 directly to step 424 without any interveningprogramming steps. For other liquid medicaments, the continuous mode ofinfusion may be appropriate. The infusion parameters entered at one ofsteps 420, 424, 428, 432, 436 could also be customized based upon thetype of cassette inserted and/or the liquid medicant to be infused.

Different types of cassettes could be distinguished by the pump 10 basedupon the length (or flexibility) of the flow-stop member (which couldhave four slightly different lengths or flexibilities), so that fourdistinct forces would be generated on the force-sensitive resistiveelement 322, or in a conventional manner based upon other structuralfeatures of the cassette.

For example, two light detectors could be disposed side by side in thetop portion of the pump, each light detector having a transmitter whichtransmits a light beam to an associated receiver. Each cassette could beuniquely identified by the presence (or absence) of two notches, eachnotch being positioned adjacent one of the light detectors. Each lightdetector would detect the presence of a notch because the light beamwould be uninterrupted when the cassette was inserted into the pump,whereas the absence of a notch would cause the light beam to beinterrupted upon insertion of the cassette. Thus, the use of two lightdetectors and two associated notch locations would allow detection offour different types of cassettes, thus allowing four pre-programmedmodes of pump operation.

A flowchart of the operating system 500 of the infusion pump 10 isillustrated in FIG. 11. The operating system 500 determines how theoperations and tasks shown in the flowchart of FIG. 9 are performed.

If the pump is in the run mode 460 shown in FIG. 9 and the pump isinfusing at a relatively low flow rate, the pump may operate in a sleepmode which utilizes a relatively low rate of power consumption from thebattery 282, such as 50 microamperes. When in the sleep mode, thecontroller 200 does not execute any instructions of the computerprogram, and its internal clocks are turned off. The pump isperiodically placed in an idle mode which utilizes an intermediate rateof power consumption, such as 8 milliamperes. When the pump is in theidle mode, the controller 200 does not execute any instructions of thecomputer program, but its internal clocks continue to run. If the pumpis in neither the sleep mode nor the idle mode, the computer program isexecuted and the internal clocks in the controller 200 run. In thisoperating mode, power is consumed at a relatively high rate, such as 17milliamperes.

Referring to FIG. 11, if the pump is not operating in the run mode 460as determined at step 502, the program branches to step 504 where any ofthe processing tasks of steps 402-436 of FIG. 9 may be performed. Asdescribed above, these tasks relate to the initial programming of theinfusion pump 10 and are user-interactive. When there are no more ofsuch tasks to be performed, for example, when the user has paused duringthe programming of the pump or has completed the pump programming, theprogram branches to step 506, where the controller 200 is placed in itsidle mode, described above, via a software command. The controller 200exits the idle mode upon the generation of an interrupt that isgenerated at step 508. The interrupt is periodically generated by thecontroller 200, for example, every 20 milliseconds.

Thus, when the pump is not in the run mode 460, the program cyclesthrough steps 502-508 where it alternately performs at step 504 one ormore of the processing tasks shown at steps 402-436 in FIG. 9 and isidled at step 506 to conserve battery power.

Under certain conditions, the pump may operate in the sleep modedescribed above. The pump may operate in the sleep mode when it is inthe run mode 460 (FIG. 9) and is pumping below a relatively low infusionrate threshold, such as five milliliters/hour.

To deliver such a low infusion rate, the motor 51 is not activatedcontinuously, but is instead turned on periodically (the motor 51 has aminimum rate at which it must be driven or else it will stall) todeliver a relatively small volume of liquid medicant, 50 microliters forexample, and then is turned off. It is when the motor 51 is turned offwhen the controller 200 is placed in the sleep mode. When the programmedinfusion rate is below the threshold, the frequency with which the motorturns on and off is determined by the programmed infusion rate. If theprogrammed infusion rate is above the threshold, the motor 51 will pumpcontinuously.

Referring to FIG. 11, at step 510, if the pump is not in a stealth mode(described below), the program branches to step 512 where a number ofprocessing tasks relating to the infusion may be performed. At step 514,the watchdog timer 250 is strobed, and at step 516 the programdetermines whether the controller 200 may be placed in the sleep mode.As described above, the controller 200 may be placed in the sleep modeif the infusion rate is less than a predetermined threshold rate. Thereare also other conditions which must be satisfied. For example, themotor 51 cannot be active, an audio beep (in response to a key beingpressed, for example) cannot be active, no timed functions can be active(such as a timed LED illumination), the backlight 220 cannot be on, andthe display 16 cannot be scrolling text. If these conditions aresatisfied, the program branches to step 520 where the power to a numberof sensors is turned off, and to step 522 where the controller 200 isplaced in its sleep mode.

The controller 200 remains in the sleep mode until it is “awakened” byany of three occurrences: 1) any key being pressed, including thebolus-request key 332; 2) the watchdog timer timing out; or 3) aone-second strobe generated by the real-time clock 210. In the absenceof conditions 1) and 2), the controller 200 will be awakened everysecond by the strobe from the real-time clock 210. Upon being awakened,the internal clocks of the controller 200 are started at step 524, andthe program branches to step 508 where it waits for the next 20 msinterrupt generated by the controller 200.

The infusion pump 10 also has a stealth mode relating to theintermittent infusion mode of FIG. 9. In this mode, the pump 10 deliversan infusion spaced at relatively large time intervals, such as minutesor hours. Between infusions, the pump is placed in a stealth mode inwhich the controller 200 is put to sleep.

FIG. 12 illustrates an off-control routine 530 that is periodicallyinvoked to determine whether the on/off switch 288 (FIG. 7) of theinfusion pump 10 has been turned off. In that case, as determined atstep 532, the program branches to step 534 where it determines if it isokay to turn the pump off (it is okay to turn the pump off as long as itis not in the run mode 460). If it is okay to turn the power off, theprogram branches to step 536. If the pump is not in the intermittentmode as determined at step 536, the power is turned off. If the pump isin the intermittent mode, the program branches to step 538, whichdetermines whether there are any more periodic doses (infusions) to bemade. If there are no more doses, the power is turned off.

If there is at least one additional dose, the pump is placed in thestealth mode at step 540. Referring back to step 510 of FIG. 11, if thepump is in the stealth mode, the program branches to step 550, whichdetermines whether the next dose in the intermittent mode is scheduledwithin the next 30 minutes. If not, the program branches to steps520-522 where the controller 200 is put to sleep.

If the next dose is within 30 minutes as determined at step 550, theprogram branches to step 552, where it determines whether the time untilthe next dose, or the time after that dose if not given, is a multipleof ten minutes. If it is, then the program branches to step 554, wherethe pump 10 generates an audible beep to the user as a reminder that thenext dose is a multiple of ten minutes away. Thus, when the intermittentinfusion mode is being used and the pump is in the stealth mode, thepatient is given three audible warnings that the next dose is imminent,a first warning at 30 minutes prior to the dose, a second warning at 20minutes prior to the dose, and a third warning at 10 minutes prior tothe dose. If the next dose is not given on schedule, a fourth warning isgenerated at the time of the dose, and three additional warnings, spaced10 minutes apart, are given after the time for the dose.

During the operation of the infusion pump 10, a number of the sensorsused to sense various conditions may be turned on only when they areactive in order to conserve battery power. The sensors that areselectively turned on include the input pressure sensor 270, the outputpressure sensor 272, the air-in-line detector 300, the shaft encoder308, the Hall-effect sensor 310 and the ambient light sensor 18. Thispowering of these sensors is controlled by a number of computer programroutines, three of which are illustrated in FIGS. 13A-13C.

Referring to FIG. 13A, a pressure sensor routine 600 may be used for theselective powering of the input and output pressure sensors 270, 272. Ifit is time to check either the input pressure or the output pressure inthe flexible tube 40 as determined at step 602, the power supplied toboth pressure sensors 270, 272 is turned on at step 604 via the line 294to the power switch 280. The program then delays (e.g. a delay of 20 ms)at step 606 to allow the sensors 270, 272 to stabilize, and then thesensed pressure is read at step 608, following which both sensors 270,272 are turned off at step 610 via the control line 294 to the powerswitch 280.

Referring to FIG. 13B, a sensor routine 620 may be used for theselective powering of the shaft encoder 308 of the motor 51. The shaftencoder 308 is active only when the motor 51 is turning, as determinedat step 622. If it is time to turn the motor 51, the power supplied tothe shaft encoder 308 is turned on at step 624 via the control line 314to the power switch 312. The program then delays at step 626 to allowthe shaft encoder 308 time to stabilize, after which time the shaft 308will automatically generate signals indicative of the rotational rateand direction of the motor shaft. When the motor stops turning, asdetermined at step 628, the power to the shaft encoder 308 is turned offat step 630 via the control line 314 to the power switch 312.

Referring to FIG. 13C, a sensor routine 640 may be used for theselective powering of the air-in-line sensor 300. If it is time to checkthe air-in-line sensor 300 as determined at step 642, the power suppliedto the air-in-line sensor 300 is turned on at step 644 via the line 304to the power switch 302. The program then delays (e.g. a delay of 2 ms)at step 646 to allow the sensor 300 to stabilize, and then the sensor300 is read at step 648, following which the sensor 300 is turned off atstep 650 via the control line 304 to the power switch 302. The routinesshown in FIGS. 13B and 13C may be performed only when the criteria forthe sleep mode are satisfied as described above in connection with step516.

The infusion pump 10 incorporates another power-saving feature in thatthe backlight 220 for the display 16 is activated only under certainconditions. If either a key on the keypad 14 is pressed or a visualalarm message is generated on the display 16, the routine 700 causes thebacklight 220 to be activated, via the control line 222, when theambient light fails to surpass a predetermined threshold, as detected bythe ambient light sensor 18.

Referring to FIG. 14, which is a flowchart of the backlight turn-onroutine 700, if there is an alarm as determined at step 702, the programbranches to step 704 where the ambient light sensor 18 is read (afterthe sensor 18 is powered up via the control line 328 connected to thepower switch 326). If the amount of ambient light detected by the sensor18 does not surpass a predetermined light threshold as determined atstep 706, then the backlight 220 is turned on at step 708 via thecontrol line 222 connected to the backlight 220. At step 710, abacklight timer, which causes the backlight 220 to be turned on only fora predetermined period of time, is then reset.

If no alarm was present as determined at step 702, then the programbranches to step 712 which determines whether a key has been pressed. Ifso, then the program performs steps 704-710 to turn on the backlight 220if the ambient light does not surpass a threshold level, as describedabove.

If no key has been pressed (and no alarm is present), the programbranches to step 714. Steps 714-720 cause the backlight 220 to beautomatically turned off after a predetermined period of time asdetermined by the backlight timer. At step 714, if the backlight is on,the program branches to step 716 where the backlight timer isincremented (the routine 700 is performed periodically, such as every 20milliseconds). At step 718, if the backlight timer is at its limit,indicating that the predetermined period of time for which the backlight220 should be illuminated has elapsed, then the program branches to step720 where the backlight 220 is turned off.

During the programming and operation, the infusion pump 10 automaticallyrecords in the non-volatile memory 208 all significant infusion data togenerate a complete historical data record which can be later retrievedfrom the memory 208 and used for various purposes, including clinicalpurposes to aid in determining how effective a particular infusiontherapy was and treatment purposes to confirm that the prescribedinfusion was actually delivered.

FIG. 15 illustrates various steps at which infusion data is recordedthat are performed during the overall pump operation shown generally inFIG. 9. The infusion data recorded in the memory 208 is set forth inTable 1 below. A number of events which trigger the storage of data arelisted in the left-hand column of Table 1, and the infusion data that isrecorded upon the occurrence of each event is listed in the right-handcolumn of Table 1. The time at which the infusion data is recorded,which is determined by the real-time clock 210, is also stored alongwith the infusion data.

TABLE 1 EVENT DATA RECORDED Power On Date and Time Program Infusionparameters. See Table 2. Run Infusion parameters. See Table 2. HoldTotal Volume Infused Restart Time of Restart Rate Changes Total VolumeInfused, Rate, Volume Alarms Total Volume Infused, Alarm Type InfusionComplete Total Volume Infused Malfunctions Total Volume Infused,Malfunction Type Resume Infusion parameters. See Table 2. MaintenanceDate Date Patient ID Patient ID Number Serial No. Serial Number LanguageChange New Language Lockout Modes Locked Out Pressure Select NewPressure Setting Bolus Request Given/Not Given, Bolus Amount TitrationNew Parameters Power Off Time of Power Off Version No. Software VersionNumber

Referring to Table 1 and FIG. 15, when the power to the infusion pump 10is turned cn, the date and time of the power turn-on is recorded. Whenthe pump is completely programmed pursuant to one of steps 420, 424,428, 432, 436 (FIG. 9) as determined at step 802, the programmedinfusion parameters are stored at step 804, along with the time of suchstorage. The particular parameters that are stored depend upon whichinfusion mode was programmed. Several examples of infusion parametersthat are stored for each of a number of infusion modes are illustratedin Table 2 set forth below.

TABLE 2 INFUSION MODE INFUSION PARAMETERS Continuous Infusion ModeInfusion Rate Volume To Be Infused Delay Time Total Bag Volume KVO RateAuto-Ramp Infusion Mode Infusion Rate Volume To Be Infused Delay TimeTotal Bag Volume Duration of Up-Ramp Duration of Down-Ramp KVO RateIntermittent Infusion Mode Total Infusion Time Number of Doses Dose TimeDose Volume KVO Rate

When the pump enters the run mode 460 (FIG. 9) as determined at step806, the time at which the run mode was begun, along with the parameterspursuant to which the infusion is performed, are stored at step 808.

At step 810, if the hold key is pressed, then the time at which the holdkey was pressed along with the total volume infused at the time the holdkey was pressed are stored at step 812. The pump also stores anyinfusion rate changes, such as changes caused by switching from acontinuous rate to a keep-vein-open (KVO) rate, or in the intermediatemode, changing from a KVO rate to a higher infusion rate, the presenceof which are detected at step 814. The new rate and the time at whichthe new rate started are stored at step 816.

At step 818, if any alarms are generated, the alarm type, the time atwhich the alarm occurred, and the total volume infused at the time ofthe alarm are recorded at step 820. If the infusion is completed asdetermined at step 822, the program branches to step 824 where the timeat which the infusion was completed is stored along with the totalvolume infused. At step 826, if there is a malfunction, the malfunctiontype, the time at which the malfunction occurred, and the total volumeinfused at the time of the malfunction are recorded at step 828.

At step 830, if the infusion is resumed (when the pump is turned back onafter having been turned off during an infusion), the time at which theinfusion is resumed along with the infusion parameters are stored atstep 832. Upon the completion of the programming of a lockout sequenceas determined at step 834 (i.e., after step 416 of FIG. 9), the time atwhich the programming of the lockout was completed, is stored along withthe infusion modes that were locked out. At step 838, upon the detectionof a bolus request (via the bolus-request key 332 in FIG. 7), the timeat which the bolus was requested is stored, along with an indicationwhether the bolus was actually given and the amount of the bolus.

Turning now to FIG. 16, the unitary molded elastomer conduit 1000 isshown in perspective view. The conduit 1000 is provided for fluidtransport, having several elongated tubular sections integral with themolded conduit for facilitating the pump chamber, clamping, fluidtransport characterization, and the like, for use with a medicalinfusion pump. FIG. 16 shows several external features molded on theoutside of the conduit 1000. Particularly, positioning features 1002 and1004 are used to align the conduit 1000 in the cassette 12 forpositioning relative to the ultrasonic piezoelectric transmitter andreceiver of the air-in-line sensor 300 which is used to detect presenceof any significant air bubbles within the conduit 1000 at region 1014(see FIG. 17) facilitating characterization of the fluid transport.Thus, self-registering features are provided to improvemanufacturability and accuracy in placement of the conduit 1000 in thecassette 12.

External features are also provided on the conduit 1000 to facilitatethe clamping function of the free flow clamp, particularly externalfeatures 1006 and 1008, and positioning feature 1010 may be positionedat the free flow clamp 60 as discussed above to facilitate clamping offof the lumen defined through the conduit 1000. As will be discussedfurther below, the molded conduit 1000 includes a plurality of integralelongated tubular sections (discussed in connection with FIG. 18) whichdefine the continuous lumen through the conduit 1000 for medicamentdelivery by fluid transport therethrough. At least a first interiorsurface of the conduit 1000 is associated with one of the plurality ofelongated tubular sections, and includes a first interior region forclamping off the lumen. Additionally, at least a second interior surfaceof the conduit 1000 is associated with another of the plurality oftubular sections, and includes a second interior region for coupling asignal across the conduit traversed to the lumen to characterize thefluid transport. The second interior region has a textured surfacerelative to the first interior region for controlling the energy fromthe signal coupled across the conduit traversed to the lumen. Thetextured surface effects the propagation of signals, e.g., ultrasonicenergy being coupled into and through the conduit 1000 at region 1014.Clamping off of the lumen of the conduit 1000, as discussed inconnection with at least the first interior surface at region 1016,facilitates clamping with the free flow clamp, e.g., features 1010 and1006 facilitate the clamping of the lumen and also facilitate the use ofan interior surface texture appropriate for the peristaltic pumpingmechanism providing sufficient clamping pressure during the pumping toensure accuracy of the swept volume of fluid medicament delivered withthe peristaltic pump.

FIG. 17 shows the conduit 1000 positioned in the cassette 12. As shownin FIG. 17, a region 1012 is positioned for receiving the peristalticpumping mechanism of the medical infusion pump. Features 1004, 1006, and1010 constrain and lock the region 1012 with the pumping area. A region1014, as discussed, is positioned in the cassette 12 for use with theair-in-line sensor 300. Additionally, regions 1018 and 1020 of theconduit 1000 provide openings in the cassette 12 for use with a straingauge or beam which is in contact with the exterior of the conduit 1000at reference numerals 1018 and 1020 respectively, allowing thecantilever strain gauge or beam to determine upstream and down-streamocclusion characteristics of the fluid transport through the lumen ofthe conduit 1000. Tubing 52 and 54, as discussed above, are coupled tothe conduit 1000 at the end regions, which end regions include a steppedopening for receiving the tubing 52 and 54 respectively at referencenumerals 1022 and 1024 providing a registered fit between the conduit1000 and the tubing 52 and 54 (see FIG. 18).

FIG. 18 shows the conduit 1000 in cross section with several elongatedtubular sections defining the continuous lumen through the conduit 1000shown as being formed integrally with the unitary molded elastomerconduit. The unitary elastomer conduit of the preferred embodiment isinjection molded on a core pin using silicone compound in a pyrogen freeenvironment. Silicone has desirable features including a relativelyconstant storage modulus or stiffness, and dynamic mechanical analysischaracteristics over temperature with minimal volume drift superior tomost conventional elastomers such as polyurethane or plasticizedpolyvinylchloride (PVC). Through the use of an elastomer such as asilicone, as opposed to a thermoplastic, the liquid injection moldingover the core pin provides for accurate and repeatable manufacture ofthe several internal and external features of the conduit 1000.

As shown in FIG. 18, the region 1012 may be received by the peristalticpumping mechanism of the medical infusion pump, which region includes aninterior surface texture of sufficient coarseness to prevent sticking ofthe silicone tube to provide adequate clamping off of the region 1012during peristaltic pumping operation to maintain clamping pressureduring drug delivery as a swept volume of medicament flows through theconduit 1000 by way of the peristaltic mechanism of the medical infusionpump. Additionally, the region 1012 is molded to ensure a predeterminedand reproducible volume therein to maintain a high degree of accuracy,e.g., plus/minus one percent, with the molded conduit 1000. The region1014 provides a tubular section which when positioned within the medicalinfusion pump at the air-in-line sensors provides sufficient coupling ofthe ultrasonic signal from its smooth outer surface through the knurledtextured portion, as discussed below, for sufficient ultrasonic energytransfer through the conduit 1000 traversed to the lumen for determiningthe presence of air in line with the fluid medicament. The knurledinterior features provide enhanced scattering at the air/wall interfaceto better differentiate between air and water or other fluids.Additionally, the external features provided at a region 1016 facilitatethe pinch-off of the lumen. As discussed above, the region 1016 providesfor a clamping action used with the free flow clamp of the cassette 12.Regions 1018 and 1020 are used with the occlusion testing as discussedabove, and regions 1022 and 1024 have stepped internal features at theends of the conduit 1000 for receiving the tubes 52 and 54 coupling thefluid medicament to the cassette module of the peristaltic pump.

FIG. 19 is a cross-sectional view of the conduit 1000, identifyingparticularly the regions 1012, 1014, and 1016 which are shown in crosssection in FIGS. 20-22. In FIG. 20, the region 1016 is shown as havingan exterior surface 1028 and a somewhat coarse interior surface 1026where the interior surface 1026 is provided as having an N4 surfacetexture. The designation N4 for the roughness specification of theinterior surface denotes that the roughness is in metric units and thatthe root-mean-squared surface roughness should not exceed 4 micrometers.The N4 roughness is sufficient to yield sufficient hold pressure toclamp off the lumen under the operation of the flow clamp, in this area,where a displaced volume is not as much an issue as would be the case inregion 1012 as shown in FIG. 21. The region 1012 in FIG. 21 provides aninterior surface 1030 and external surface 1032. The interior surface atFIG. 21 is provided as having surface texture of 220 grit cross-hatched,honed to yield sufficient hold pressure to clamp-off the lumen duringpump operation. In the current embodiment, the textures of the interiorsurfaces 1026 and 1030 are identical. The region 1014 is shown in crosssection in FIG. 22 with a knurled interior region 1034 and a smoothexternal region 1036, providing textured surfaces particularly suitedfor ultrasonic signal energy transfer through the region 1014. Theinterior surface texture at 1034 and the exterior surface texture at1036 are provided in the described embodiment for the use of ultrasonicdetection of air-in-line conditions to characterize the fluid flowthrough the lumen. In particular, the smooth surface 1036 facilitatescoupling of the ultrasonic signal into the region 1014 even in thepresence of fluids external to the conduit 1000, so as to assure that anaccurate assessment of the air-in-line detection is provided in suchconditions. Additionally, the knurled interior surface texture 1034facilitates scattering within an anechoic chamber structure for theultrasonic signal propagating across the lumen of the conduit 1000. Thedegree of this scattering is dependent upon the relative impedances ofthe conduit and the contents within the lumen of the conduit 1000. Thusthe matching of the signal transmission into and through the conduit1000 allows for illumination with a sufficient signal to noise ratio(SNR) which facilitates the accurate amplitude detection of the signalat the air-in-line sensor 300.

Modifications and alternative embodiments of the invention will beapparent to those skilled in the art in view of the foregoingdescription. This description is illustrative only, and the invention isdefined by the appended claims.

What is claimed is:
 1. A unitary molded elastomer conduit for fluidtransport, the conduit comprising: a plurality of elongated tubularsections defining a continuous lumen therethrough; a first interiorsurface of the conduit associated with one of the plurality of elongatedtubular sections comprising a first interior region for clamping offsaid lumen; and a second interior surface of the conduit associated withanother of the plurality of elongated tubular sections comprising asecond interior region for coupling an ultrasonic energy signal acrossthe conduit transverse to the lumen to characterize the fluid transportsaid second interior region having a textured surface relative to saidfirst interior region effecting the propagation of the transmission ofthe signal energy from the signal coupled across the conduit transverseto the lumen thus enhancing the discrimination of entrained airdetection.
 2. A conduit as recited in claim 1 wherein said secondinterior surface is textured relative to said first interior region forimpedance-dependent transmission of the signal energy.
 3. A conduit asrecited in claim 1 comprising a third interior surface of the conduitassociated with another of the plurality of elongated tubular sectionscomprising a third interior region for receiving a peristaltic pumpingmechanism for constraining a pumping area of the conduit.
 4. A conduitas recited in claim 1 wherein said second interior surface is knurledrelative to said first interior surface.
 5. A conduit as recited inclaim 1 wherein said plurality of elongated tubular sections areinjection molded over a core pin to form the unitary molded elastomerconduit.
 6. A conduit as recited in claim 1 wherein the elastomercomprises a pyrogen free silicone compound.
 7. A conduit as recited inclaim 1 comprising an exterior surface relative to said second interiorsurface of the conduit associated with the elongated tubular section,the exterior surface for coupling the signal across the conduittransverse to the lumen.
 8. A conduit as recited in claim 7 wherein saidsecond interior surface and said exterior surface of the conduit areprovided for coupling ultrasonic energy transverse to the lumen tocharacterize the fluid transport.
 9. A conduit as recited in claim 8wherein said exterior surface relative to said second interior surfaceof the conduit associated with the plurality of elongated tubularsections is smooth relative to the exterior surfaces of others of theassociated plurality of elongated tubular sections, the relativelysmooth exterior surface being provided for improving the acoustictransmission of the signal across the conduit.
 10. A conduit as recitedin claim 1 comprising one or more external features for positioning saidplurality of elongated tubular sections of the conduit for fluidtransport and characterization.
 11. A conduit as recited in claim 10wherein said one or more external features comprise differentthicknesses for closing the tubular section to facilitate clamping offof the lumen of the conduit.
 12. A method of making a unitary moldedelastomer conduit for use with a medical infusion pump, the conduitcomprising: providing a plurality of elongated tubular sections defininga continuous lumen therethrough; molding a first interior surface of theconduit associated with one of the plurality of elongated tubularsections comprising a first interior region for clamping off said lumen;molding a second interior surface of the conduit associated with anotherof the plurality of elongated tubular sections comprising a secondinterior region for coupling a signal across the conduit transverse tothe lumen to characterize the fluid transport, said second interiorregion having a textured surface relative to said first interior regiondirecting the signal energy from the signal coupled across the conduittransverse to the lumen; and said first interior region and itsassociated elongated tubular section being positioned relative to theperistaltic pumping mechanism of the medical infusion pump.
 13. A methodas recited in claim 12 comprising the step of molding a third interiorsurface of the conduit associated with another of the plurality ofelongated tubular sections for providing a pumping area which receives aperistaltic mechanism on the conduit.
 14. A method as recited in claim12 comprising the step of texturing the surface of the second interiorregion for providing impedance-dependent transmission of the energy fromthe signal coupled across the conduit traverse to the lumen forenhancing the discrimination of entrained air detection.
 15. A method asrecited in claim 12 comprising the step of clamping the lumen byproviding an external force at external features on the molded secondinterior surface.
 16. A method as recited in claim 12 wherein saidproviding step comprises forming a plurality of elongated tubularsections having one or more external features receivable in a cassettewhich is insertable into the medical infusion pump.
 17. A method asrecited in claim 16 wherein said external features are molded forpositioning the plurality of elongated tubular sections of the conduitat predetermined locations of the cassette relative to the peristalticpumping mechanism of the medical infusion pump.
 18. A method as recitedin claim 17 comprising the steps of providing external features for selfpositioning of the conduit.
 19. A method as recited in claim 18 whereinthe providing of the external features prevents moving of the conduitduring pumping cycles.
 20. A method as recited in claim 17 wherein saidexternal features are molded with an outer collar or ring on the outsideof the conduit for positioning relative to the peristaltic pumpingmechanism of the medical infusion pump.
 21. A method as recited in claim20 comprising the step of providing an inner collar to position theinterior conduit for registration with coupled tubing.
 22. A method asrecited in claim 20 wherein said external features provide forregistration of at least said first interior region and the associatedelongated tubular section relative to the peristaltic pumping mechanismof the medical infusion pump.
 23. A method as recited in claim 20wherein said external features prevent the conduit from twisting insidesaid cassette to maintain a uniform storage modulus for the conduitinside said cassette.
 24. A method of infusing a medicament with amedical infusion pump, the method comprising the steps of: molding aunitary elastomer conduit having a plurality of tubular sectionsdefining a continuous lumen therethrough; securing the conduit in acassette for being received by the medical infusion pump; providing afirst interior surface of the conduit associated with one of theplurality of elongated tubular sections with a first interior region forclamping off the lumen; providing a second interior surface of theconduit associated with another of the plurality of elongated tubularsections with a second interior region for coupling a signal across theconduit traversed to the lumen to characterize fluid transport;texturing the surface relative to the first interior region tofacilitate the transmission of the signal coupled across the conduittraversed to the lumen; and receiving a liquid medicament at theconduit, the first interior region and the associated tubular sectionbeing positioned relative to the peristaltic pumping mechanism of themedical infusion pump for fluid transport through the continuous lumendefined by the plurality of elongated tubular sections of the conduit.25. A method as recited in claim 24 comprising the step of providingmolded features on the outside of the conduit for locating the pluralityof elongated tubular sections of the conduit within the cassette.
 26. Amethod as recited in claim 24 providing a smooth external surfacerelative to the second interior region having the textured interiorsurface to direct the signal energy from the signal coupled across theconduit traversed to the lumen.
 27. A method as recited in claim 26comprising the step of providing an ultrasonic signal at the secondinterior region for coupling across the conduit traversed to the lumento characterize the fluid transport.
 28. A method as recited in claim 27comprising the step of providing a coarse interior surface of theconduit to prevent sticking of the surface while facilitating pumpingtherethrough.
 29. A medical infusion pump comprising: a pump chambercassette conduit comprising a plurality of elongated tubular sectionsdefining a continuous lumen therethrough; a first interior surface ofthe conduit associated with one of the plurality of elongated tubularsections comprising a first interior region for clamping off said lumen;and a second interior surface of the conduit associated with another ofthe plurality of elongated tubular sections comprising a second interiorregion for coupling a signal across the conduit transverse to the lumento characterize the fluid transport, said second interior region havinga textured surface relative to said first interior region directing thesignal energy from the signal coupled across the conduit transverse tothe lumen; a tube for receiving a liquid medicament at the conduit, thefirst interior region and the associated tubular section beingpositioned relative to the peristaltic pumping mechanism of the medicalinfusion pump for fluid transport through the continuous lumen definedby the plurality of elongated tubular sections of the conduit; and aperistaltic pump mechanism for transporting the liquid medicament acrossthe conduit of the pump chamber cassette.
 30. A medical infusion pump asrecited in claim 29 wherein said conduit comprises one or more externalfeatures for positioning the plurality of elongated tubular sections ofthe conduit in the pump chamber cassette for fluid transport by thepump.